Data / Medical devices / Collector, Ostomy
Collector, Ostomy (EXB): 54 FDA-registered makers in 18 countries
54 establishments in 18 countries are registered with the FDA to make Collector, Ostomy (product code EXB, Class 1, 21 CFR 876.5900). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 102 510(k) clearances under this code, the latest on October 6, 2025, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EXB
- Device class
- 1
- Regulation
- 876.5900
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| China | 15 |
| United States | 14 |
| United Kingdom | 4 |
| Denmark | 3 |
| Mexico | 3 |
| Ireland | 2 |
| Turkey | 2 |
| Dominican Republic | 1 |
| Australia | 1 |
| Czechia | 1 |
| Brazil | 1 |
| Hungary | 1 |
| Costa Rica | 1 |
| Lithuania | 1 |
| India | 1 |
| Poland | 1 |
| Latvia | 1 |
| New Zealand | 1 |
Makers of Collector, Ostomy
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Convatec Dominican Republic, Inc. | Haina San Cristobal, Dominican Republic | Manufacturer | 1 | June 16, 1981 | 0 | 0 | 0 | api.fda.gov |
| Convatec Limited | Deeside Flintshire, United Kingdom | Manufacturer | 1 | June 16, 1981 | 0 | 0 | 0 | api.fda.gov |
| ConvaTec Limited, GDC Building | Deeside Flintshire, United Kingdom | Specification developer | 1 | June 16, 1981 | 0 | 0 | 0 | api.fda.gov |
| Aeris Environmental Ltd | Rosebery New South Wales, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alp Ecology S.R.O. | Ostrava - Privoz Ostrava-Mesto, Czechia | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan City Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Covington, GA, United States | Contract sterilizer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Casex, Ltda | Curitiba Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coloplast (china) Ltd. | ZHUHAI Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coloplast A/S | HUMLEBAEK Hovedstaden, Denmark | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coloplast Hungary KFT | TATABANYA Komarom-Esztergom, Hungary | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Concarey Medical Technology Co., Ltd | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coloplast A/S - Mordrup Site | Espergaerde Hovedstaden, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coloplast Costa Rica SA | La Lima, Guadalupe Cartago, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Hong De Medical Plastic Products Co. Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Furine Aps | Skaevinge Hovedstaden, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Rollmed Co.,ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Incorporated | Libertyville, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Incorporated | Stuarts Draft, VA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister ULC | REHINS BALLINA Mayo, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Hendry Medical Appliance Co., Ltd | Xiaogan City Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Lietuva UAB | Kaunas district, Lithuania | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Medical India Private Limited | Bawal, Rewari Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jago-Pro SP. Z O.O. | JAWORZNO Slaskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Ostup Medical Products Co. Ltd. | Nanjing Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kem Enterprises Acquisition, LLC | Grand Rapids, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Konfort Ozel Saglik Hizmetleri Tibbi Malz. San Ve Tic Ltd Sti | Eskisehir, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kosemed Ortopedi Sanayi Ve Ticaret Ithalat Ihracat Anonim Sirketi | Salihli Manisa, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kutol Products Company | Sharonville, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lumaclean, LLC | Concord, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Molding & Manufacturing de Mexico S. de R.L. de C.V. | Reynosa Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanjing Anjian Medical Device Co.,ltd. | Nanjing Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuance Medical, LLC | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ostoform Ltd | Mullingar Westmeath, Ireland | Exporter to the US, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ostomy Assist | Clayton, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pdi Emea Ltd | Corby Northamptonshire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Para El Cuidado De La Salud | NOGALES Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remedy Medical Manufacturing | Mesa, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Salts Healthcare Limited | Aston Birmingham, United Kingdom | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sarasota Medical Products | Sarasota, FL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEI Medical S.A. de C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Lions Industrial Co.,ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Haoshide Medical Products Co.,ltd | Shaoxing Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SIA Elas Baltic | Jelgava, Latvia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SP-Meditec | Peachtree City, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stomagienics, Inc. | Greenville, SC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Kangyouwei Medical Technology Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Insides Company Limited | Auckland, New Zealand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tongxiang Bao-Health Medical Instrument Co., Ltd. | Tongxiang Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou Zuoyou Medical Technoloyg Co.,ltd. | Wenzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.